U.S. patent application number 09/929700 was filed with the patent office on 2001-12-20 for tissue opening locator and everter and method.
Invention is credited to Kirsch, Wolff M., Zhu, Yong Hua.
Application Number | 20010053922 09/929700 |
Document ID | / |
Family ID | 27555652 |
Filed Date | 2001-12-20 |
United States Patent
Application |
20010053922 |
Kind Code |
A1 |
Zhu, Yong Hua ; et
al. |
December 20, 2001 |
Tissue opening locator and everter and method
Abstract
An apparatus for facilitating the locating, everting, and
closing of an opening in a blood vessel. The apparatus can include
a closure instrument having an elongated member defining a
longitudinal axis and proximal and distal ends. The elongated
member has a vacuum lumen extending at least a portion of the
length thereof for conveying a vacuum and terminating in a vacuum
port adjacent the distal end of the elongated member. The distal
end of the elongated member is dimensioned to be positioned
proximal a vessel opening in a blood vessel whereby vessel edge
portions defining the vessel opening are at least partially drawn
toward the vacuum port in response to a vacuum conveyed through the
vacuum lumen. At least one surgical clip is mounted adjacent the
distal end of the elongated member and is adapted to be formed to
an at least partially formed condition thereof. The one clip is
positioned with respect to the vacuum port so as to engage the
vessel edge portions drawn toward the vacuum port when the clip is
moved to the formed condition, thus at least partially closing the
vessel opening. A method for locating, everting, and closing an
opening in a blood vessel is also disclosed.
Inventors: |
Zhu, Yong Hua; (Loma Linda,
CA) ; Kirsch, Wolff M.; (Redlands, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
620 NEWPORT CENTER DRIVE
SIXTEENTH FLOOR
NEWPORT BEACH
CA
92660
US
|
Family ID: |
27555652 |
Appl. No.: |
09/929700 |
Filed: |
August 13, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
09929700 |
Aug 13, 2001 |
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09325982 |
Jun 4, 1999 |
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6287322 |
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09325982 |
Jun 4, 1999 |
|
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|
09092282 |
Jun 5, 1998 |
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|
09092282 |
Jun 5, 1998 |
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|
08984757 |
Dec 4, 1997 |
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|
08984757 |
Dec 4, 1997 |
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|
08943369 |
Oct 3, 1997 |
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08943369 |
Oct 3, 1997 |
|
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08764611 |
Dec 5, 1996 |
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6004341 |
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60009643 |
Dec 8, 1995 |
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Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 17/0682 20130101;
A61B 17/122 20130101; A61B 17/128 20130101; A61B 17/02 20130101;
A61B 17/0206 20130101; A61B 17/3439 20130101; B29K 2067/003
20130101; A61B 17/10 20130101; A61B 17/0057 20130101; A61B 2017/306
20130101; A61B 17/08 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. An apparatus for locating an opening in tissue, comprising: an
elongated member having a lumen formed therein and having a vacuum
source attached for conveying a vacuum through said lumen, said
elongated member having a vacuum port adjacent the distal end of
said elongated member, said vacuum port positioned on said opening
and withdrawing body liquid therethrough and through said
lumen.
2. The apparatus of claim 1, further comprising a body fluid
visualization port adjacent the proximal end of said elongated
member.
3. The apparatus of claim 2 wherein said visualization port is a
blood visualization port.
4. The apparatus of claim 1, wherein the elongated member defines a
distal axial opening in communication with the vacuum lumen, the
distal axial opening comprising the vacuum port.
5. An apparatus for locating an opening in tissue, comprising: a
suction catheter having a distal end and a proximal end; a suction
port positioned near said distal end of said suction catheter; and
a fluid detection port position near the proximal end of said
suction catheter.
6. The apparatus of claim 5, wherein said fluid detection port
comprises means for determining the nature of the fluid from said
opening to determine the location of said opening.
7. The apparatus of claim 5, further comprising a tissue modifying
apparatus adjacent said distal end of said suction catheter.
8. The apparatus of claim 7, wherein said modifying apparatus
comprises a closure device for closing said opening.
9. The apparatus of claim 7, wherein said modifying apparatus
comprises a device for enlarging said opening.
10. The apparatus of claim 7, wherein said modifying apparatus
comprises a tissue therapy device.
11. The apparatus of claim 5, wherein said suction port comprises
an edge eversion device for said opening.
12. The apparatus of claim 5, further comprising a suction catheter
holding device for maintaining the position of said catheter on
said opening.
13. The apparatus of claim 5, wherein said suction port comprises
the distal opening of said suction catheter.
14. A method for modifying an opening in tissue, comprising:
applying a vacuum to the tissue adjacent the opening; and modifying
the tissue adjacent the tissue opening.
15. The method according to claim 14, wherein modifying the tissue
adjacent the tissue opening comprises everting the edges defining
the opening.
16. The method according to claim 14, wherein modifying the tissue
adjacent the tissue opening comprises therapeutically treating the
tissue.
17. The method of claim 14, further comprising maintaining the
vacuum to hold a modifying catheter in place on the opening.
18. A method for locating a vessel opening in a blood vessel,
comprising the steps of: applying a vacuum to the general area
surrounding a vessel opening such that a mixture of blood and clear
bodily fluid is suctioned; and applying the vacuum closer to the
vessel opening such that less clear bodily fluid and more blood is
suctioned; and applying the vacuum completely over the vessel
opening such that only blood is suctioned; and applying a vacuum to
the vessel opening such that vessel edge portions defining the
vessel opening assume an everted condition.
19. The method according to claim 18, including the step of
providing an instrument having a guidewire guide that guides the
instrument toward the vessel opening.
20. A device to facilitate the closure of wounds in the vasculature
of a patient comprising: a body portion having a retracting portion
having two movable halves extending away from and substantially
perpendicular to said body portion, said halves forming a channel
extending completely through said retracting portion; and a handle
portion connected to said body portion which controls the movement
of the two movable halves.
21. The device of claim 20, wherein said handle portion comprises
two handles and a locking mechanism.
22. The device of claim 21, wherein the device is formed of a first
and second member connected by a hinge, and one movable retracting
portion half and one handle half is disposed on each member.
23. The device of claim 22, wherein the handle portion and hinge
are adapted so that movement of the retracting portion halves
toward each other is effected by moving the handles away from each
other.
24. The device of claim 21, wherein the locking mechanism comprises
a toothed arcuate stop member extending from the first handle and a
release member extending from a second handle, and the release
member includes a stop adapted to releasably engage the stop member
teeth.
25. The device of claim 21, wherein the handles are biased away
from each other.
26. The device of claim 24, wherein the release member stop is
biased into engagement with the stop member teeth.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S.
application Ser. No. 09/092,282, filed Jun. 5, 1998, which is a
continuation-in-part of U.S. application Ser. No. 08/984,757, filed
Dec. 4, 1997, which is a continuation-in-part of U.S. application
Ser. No. 08/943,369, filed Oct. 3, 1997, which is a
continuation-in-part of U.S. application Ser. No. 08/764,611, filed
Dec. 5, 1996, which claims the benefit of U.S. Provisional
Application Ser. No. 60/009,643 filed Dec. 7, 1995.
FIELD OF THE INVENTION
[0002] The present invention relates to a system which assists in
the locating of openings in tissue, including punctures, and
facilitates the treatment, diagnosis or revision, of those areas.
More specifically, in the case of closure of the opening, the
invention relates to devices which aid in locating the opening,
isolating the opening, and everting the edges of the opening, in
order to facilitate closure of the opening.
BACKGROUND OF THE INVENTION
[0003] In many medical procedures, there is a necessity to locate
an opening in tissue so that some form of treatment, diagnosis or
revision, can be applied to that opening. For example, in order to
use transluminal balloon angioplasty an opening must be created in
order to insert a balloon; this opening must be later located to be
closed. Transluminal balloon angioplasty is used in the treatment
of peripheral vascular disease to increase or restore blood flow
through a significantly narrowed artery in a limb; it is also used
in the treatment of blockage of the coronary arteries. In fact,
coronary angioplasty has emerged as a major viable alternative to
bypass surgery for revascularization of stenotic and occluded
coronary arteries. Unlike bypass surgery, angioplasty does not
require general anesthesia, opening of the chest wall, use of a
heart-lung machine, or transfusion of blood. Angioplasty is not
only less invasive and less traumatic to the patient, it is also
less expensive because of the shorter hospital stay and shorter
recovery time.
[0004] Transluminal balloon angioplasty is performed by first
inserting a hollow needle through the skin and into the patient's
femoral artery. A guidewire is advanced through the hollow needle
and into the artery, then along the patient's vasculature toward
the site of the blocked blood vessel or heart valve to be treated.
X-ray imaging is used to help move the guidewire through the
vascular system and into position just past the stenosis to be
treated. A balloon catheter is then threaded over the guidewire and
advanced until the deflated balloon is within the stenosis. The
balloon is then repeatedly inflated to widen the narrowed blood
vessel. After the procedure is complete, the catheter and guidewire
are withdrawn from the blood vessels and the patient.
[0005] Angiography, which is used to detect diseases that alter the
appearance of blood vessels, is performed in a similar manner. A
hollow needle is first inserted through the skin and into the
femoral artery, and a guidewire is then inserted through the needle
and into the affected blood vessel. A catheter is then threaded
over the guidewire and into the blood vessel to be examined, using
x-ray imaging to guide the catheter to the desired position.
Contrast medium is then injected, and a rapid sequence of x-ray
pictures are taken so that blood flow along the affected vessel can
be studied. Once complete, the catheter and guidewire are removed
from the patient's body.
[0006] After the catheter and guidewire used during angioplasty or
angiography are removed, the puncture wound in the femoral artery
must be closed and the bleeding through the puncture site in the
artery stopped. Currently, ice packs and/or pressure are applied to
the artery for a period lasting up to several hours in an attempt
to stop the bleeding. There exists, however, a significant chance
that upon movement by the patient, the wound will reopen and begin
bleeding again. Although efforts have been made to close the
puncture wound using staples, clips, and sutures, they have been
unsuccessful, largely due to the inability to clearly locate and
visualize the puncture wound in the femoral artery.
[0007] Other wounds in the vasculature of a patient can also be
difficult to locate and access. Thus, a device and method to
facilitate the location of such wounds in the vasculature of a
patient, such as femoral artery puncture wounds following
transluminal balloon angioplasty and angiography, would be
extremely beneficial. A device having the ability to aid in
locating and isolating the puncture wound and facilitating the
closure of the wound by everting the edges of the wound opening and
then using staples, clips, sutures, plugs or adhesives would
eliminate the prolonged bleeding currently associated with such
wounds.
SUMMARY OF THE INVENTION
[0008] The preferred form of the invention facilitates the location
of the tissue opening, e.g., an opening in a vessel. The purpose of
such location is to allow for the performing of other medical
procedures on the opening or surrounding tissue. These procedures
include but are not limited to therapeutic (e.g., radiation, drug
delivery, etc.), closure of the opening, or modification of the
opening (e.g., enlarging the opening) procedures. Furthermore, the
apparatus is capable of holding itself or another device on or near
the opening by the apparatus's suction, which is preferably
continuous but may be intermittent.
[0009] An apparatus for facilitating closure of an opening in a
blood vessel, which includes a closure instrument having an
elongated member defining a longitudinal axis with proximal and
distal ends. The elongated member has a vacuum lumen extending at
least a portion of the length thereof for conveying a vacuum and
terminating in a vacuum port adjacent the distal end of the
elongated member. The distal end of the elongated member is
dimensioned to be positioned proximal a vessel opening in a blood
vessel whereby vessel edge portions defining the vessel opening are
at least drawn toward the vacuum port in response to a vacuum
conveyed through the vacuum lumen. At least one surgical clip,
preferably, two, is mounted adjacent the distal end of the
elongated member and is adapted to be formed to an at least
partially formed condition thereof. The one clip is positioned with
respect to the vacuum port to engage the vessel edge portions drawn
toward the vacuum port upon movement of the one clip to the formed
condition thereof to generally approximate the vessel edge portions
to at least partially close the vessel opening.
[0010] The apparatus may further include a clip forming member
mounted to the elongated member and engageable with the one clip.
The clip forming member is movable relative to the elongated member
to move the one clip to the formed condition thereof. Preferably,
first and second clip forming members are mounted to the elongated
member in diametrically opposed relation.
[0011] In another preferred embodiment, an apparatus for
facilitating closure of an opening in a blood vessel, includes an
elongated member having a vacuum lumen extending at least a portion
of the length thereof for conveying a vacuum and terminating in an
axial vacuum port, a source of vacuum connectable to the elongated
member in communication with the vacuum lumen whereby vacuum forces
conveyed through the vacuum lumen and vacuum port cause vessel edge
portions defining the vessel opening to be at least partially drawn
into the vacuum port such that the vessel edge portions assume a
general everted condition, and a pair of surgical clips releasably
mounted to the distal end of the elongated member adjacent the
vacuum port and positioned to engage the vessel edge portions drawn
into the vacuum port upon movement of the surgical clips to
respective formed conditions thereof to thereby approximate the
vessel edge portions to at least partially close the vessel
opening. The apparatus may further include a manually actuable clip
forming mechanism mounted to the elongated member. The clip forming
mechanisms are movable to move the surgical clips to respective
formed conditions thereof.
[0012] A method for locating a vessel opening in a blood vessel is
also disclosed. The method includes the steps of applying a vacuum
to the blood vessel adjacent the vessel opening such that the
apparatus applying the vacuum first locates the area surrounding
the vessel opening by drawing a mixture of blood and bodily fluid,
then isolates the exact location of the vessel opening by being
moved to the location where only blood is drawn. Once the location
and isolation of a vessel opening is achieved, other medical
procedures can be performed on the opening or its surrounding
tissue. These medical procedures can be therapeutic (drug or
radiation delivery) or closing or modifying (e.g. enlargement of
vessel opening) in type. Also, once the vessel opening has been
isolated, the further vacuum application everts vessel edge
portions defining the vessel opening. Once eversion of the vessel
edge portions occur, closing techniques can be used to close the
opening.
[0013] Due to the use of a vacuum, contaminants and blood clots are
cleaned off the puncture site allowing better healing of the wound.
Also, re-entry is made easier and less scarring is produced.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a side view of a portion of a human body, showing
the site where the femoral artery is typically accessed and
punctured during angioplasty or angiography.
[0015] FIG. 2 is a perspective view of one embodiment of the wound
closure device of the present invention.
[0016] FIG. 3 is an exploded perspective view of the wound closure
device of the present invention.
[0017] FIG. 4 is a cross-sectional view of a portion of a human
body, showing the femoral artery accessed via a hollow needle, and
a guidewire having an inflatable balloon attached, inserted through
the hollow needle and into the femoral artery.
[0018] FIG. 5 is a side view of the distal end of a surgical clip
applicator to be used in conjunction with the wound closure device
of the present invention.
[0019] FIG. 6 is a partial cross-sectional view of a portion of a
human body, showing the femoral artery having a guidewire
positioned therein, and a perspective view of the retractor of the
present invention positioned over the guidewire, with its distal
tip at the site of the puncture in the femoral artery.
[0020] FIG. 7 is a side view of the retractor with its cap removed
and the wings of the surgical clip applicator inserted into the
grooves within the retractor.
[0021] FIG. 8 is a cross-sectional view of the clip applicator and
retractor taken along line 8-8 in FIG. 7.
[0022] FIG. 9 is a perspective view of an alternate embodiment of a
femoral artery closure device in accordance with the present
invention.
[0023] FIG. 10 is an exploded perspective view of the alternate
embodiment of the femoral artery closure device illustrated in FIG.
9.
[0024] FIG. 11 is a side view of the 2 halves of the retractor of
FIGS. 9 and 10 separated slightly and having a dilator inserted
therethrough.
[0025] FIG. 12 is a cross-sectional view of the distal end of the
retractor having a dilator and a guidewire inserted
therethrough.
[0026] FIG. 13 is a side view of the components of the femoral
artery localization and closure assembly.
[0027] FIG. 14 is a side view of the 2 halves of the retractor
separated slightly and having a surgical clip applicator with an
applicator guide and a guidewire inserted therethrough.
[0028] FIG. 15 is a top view of the surgical clip applicator guide
of the present invention.
[0029] FIG. 16 is a side view of the clip applicator guide, having
a guidewire inserted therethrough.
[0030] FIG. 17 is an enlarged perspective view of a dilator having
a removable double-sleeved balloon at its distal end.
[0031] FIG. 18 is an enlarged perspective view of the dilator of
FIG. 17 with the sleeves of the balloon inflated.
[0032] FIG. 19 is an enlarged perspective view of the dilator of
FIG. 18 having the retractor inserted between the sleeves of the
balloon.
[0033] FIG. 20 is an enlarged perspective view of the dilator and
retractor of FIG. 19 with the dilator removed, illustrating the
tunnel formed by the retractor and the outer sleeve of the
balloon.
[0034] FIG. 21 is a perspective view of another alternate
embodiment of a retractor in accordance with the present
invention.
[0035] FIG. 22 is an exploded perspective view of the alternate
embodiment of the retractor illustrated in FIG. 21.
[0036] FIG. 23 is a perspective view of an alternate embodiment of
a dilator having a double-sleeved balloon and a distal balloon
mounted thereon in accordance with the present invention.
[0037] FIG. 24 is a top view of another embodiment of the
double-sleeved balloon, illustrating the I-shaped inner sleeve.
[0038] FIG. 25 is a perspective view of the alternate embodiment of
the dilator of FIG. 23, showing the balloons inflated.
[0039] FIG. 26 is a cross-sectional view of the dilator of the
present invention, illustrating the various lumens in the
dilator.
[0040] FIG. 27 is a side view of the distal end of a surgical clip
applicator with an indicator tube mounted thereon.
[0041] FIG. 28 is a perspective view of an alternate embodiment of
a retractor of the present invention, shown in a closed
position.
[0042] FIG. 29 is a perspective view of an alternate embodiment of
a retractor of the present invention, shown in an open
position.
[0043] FIG. 30 is a side view of a dual-lumen indicator tube of the
present invention, having a guidewire inserted through its central
lumen.
[0044] FIG. 31 is a side view of the dual-lumen indicator tube of
the present invention, with the retractor mounted thereon.
[0045] FIG. 32 is a perspective view of an apparatus for
facilitating closure of an opening in a vascular organ illustrating
the vascular closure instrument and a vacuum source connected to
the closure instrument.
[0046] FIG. 33 is an enlarged isolated view of the distal end of
the closure instrument illustrating the pair of clips releasably
mounted to the instrument.
[0047] FIG. 34 is a cross-sectional view of the closure instrument
in a non-actuated condition illustrating positioning of the distal
end of the closure instrument proximal the vascular opening.
[0048] FIG. 35 is an enlarged isolated view of the distal end of
the closure instrument in the non-actuated condition proximal the
vascular opening.
[0049] FIG. 36 is a cross-sectional view of the closure instrument
illustrating the closure instrument in an actuated condition.
[0050] FIG. 37 is an enlarged isolated view of the distal end of
the closure instrument in the actuated condition illustrating the
surgical clips formed to close the vascular opening.
[0051] FIG. 38 is a perspective view of an alternate embodiment of
the vascular closure instrument of FIG. 32.
[0052] FIG. 39 is an enlarged isolated view of the distal end of
the closure instrument of FIG. 38.
[0053] FIG. 40 is a cross-sectional view of a vessel opening and
its surrounding, showing a tissue opening locator drawing both
blood and other bodily fluid.
[0054] FIG. 41 is a cross-sectional view of a vessel opening and
its surrounding, showing a tissue opening locator solely drawing
blood since the located has isolated the tissue opening.
[0055] FIG. 42a is a front view of a tissue opening locator with a
guidewire lumen located on its outside.
[0056] FIG. 42b is a front view of a tissue opening locator with a
guidewire lumen located inside.
[0057] FIG. 43 is a cross-sectional view of a vessel opening and
its surrounding, showing a tissue opening locator with medical
procedure deliver devices located both inside and outside the
tissue opening locator.
[0058] FIG. 44 is a cross-sectional view of a vessel opening and
its surrounding area, showing a guidewire that enters the vessel
opening.
[0059] FIG. 45 is a cross-sectional view of a vessel opening and
its surrounding area, showing a tissue opening locator locate the
vessel opening.
[0060] FIG. 46 is a cross-sectional view of a vessel opening and
its surrounding area, showing a tissue opening locator isolate a
vessel opening and evert the vessel opening edges.
[0061] FIG. 47 is cross-sectional view of a vessel opening and its
surrounding, showing a tissue opening locator an attached general
closure device.
[0062] FIG. 48 is a top view of an alternate embodiment of a
retractor having features of the present invention, shown in an
open position.
[0063] FIG. 49 is a top view of the retractor of FIG. 48, shown in
a closed position.
[0064] FIG. 50 is a bottom perspective view of the retractor of
FIG. 48.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT INTRODUCTION
[0065] Although the description which follows details the location,
eversion, and closure of a puncture wound in a femoral artery, the
present invention is not intended to be limited to use only with
the femoral artery. Rather, the description which follows is
exemplary and preferred only, and those of skill in the art can
readily modify the apparatus and method described below to use with
other types of tissue openings.
[0066] Referring first to FIG. 1, there is shown a side view of a
portion of a human body, showing a site 5 where a femoral artery 10
is typically accessed and punctured during angioplasty or
angiography. During these procedures, a hollow needle 15 is first
inserted through the skin and into the femoral artery 10. A
guidewire 20 is then inserted through the proximal end of the
hollow needle 15 and into the artery 10, as illustrated in FIG. 4,
and the needle 15 is withdrawn from the patient. The guidewire 20
is advanced through the patient's vasculature, often using x-ray
imaging as an aid in directing the guidewire 20 to the desired
location.
[0067] Once the guidewire 20 is in the desired location, a catheter
is used. The proximal end of the guidewire 21 is inserted into the
distal end of the catheter, and the catheter is threaded over the
guidewire 20 and advanced to the desired location. In the case of
angioplasty, the catheter has an inflatable balloon attached at its
distal end. Once in position within the stenosis, the balloon is
repeatedly inflated and deflated to widen the narrowed blood
vessel. In the case of angiography, a catheter is threaded over the
guidewire 20 as just described and into the blood vessel to be
examined. Contrast medium is then injected, and a rapid sequence of
x-ray pictures are taken so that blood flow along the affected
vessel can be studied.
[0068] After either of these procedures is completed, the catheter
and guidewire 20 are withdrawn from the blood vessel and the
patient. The puncture wound 25 in the femoral artery 10 caused by
the insertion of the hollow needle 15, guidewire 20 and catheter
must be closed and the bleeding through the puncture site 25 in the
artery 10 stopped.
[0069] Construction of the Retractor
[0070] In order to facilitate the closure of the wound 25 in the
femoral artery 10, a retractor 30 is employed. The retractor 30,
illustrated in FIGS. 2 and 3, comprises a body portion 35 and a cap
40. The body 35 of the retractor 30 has a narrow, tapered distal
end 37, and a broader circular proximal end 41. The device 30 has
two handles 43, 45 located on its body 35, one on each half 35a,
35b. The handles 43, 45 are positioned approximately one-third of
the way from the proximal end of the retractor 41, and extend
laterally from the body of the retractor 35. These handles 43, 45
assist the user in handling the device 30. The retractor 30 also
comprises a circular cap 40 at its proximal end 41, having a hole
47 therethrough. This hole 47 extends into a channel 50 which runs
the entire length of the device 30.
[0071] As illustrated in FIG. 3, the cap 40 and body 35 of the
retractor 30 comprise three separable pieces: the cap portion 40
and the two halves of the body portion 35a, 35b. The removable cap
40 is internally threaded 55. The proximal end 39 of the two halves
of the body 35a, 35b are externally threaded 60, and are adapted to
removably receive the cap 40. Each half of the body of the
retractor 35a, 35b has a semi-circular groove 65 on its flat
internal surface 67. When the cap 40 is securely screwed onto the
two halves of the body 35a, 35b as illustrated in FIG. 2, the three
pieces are joined together, and the semicircular grooves 65 form a
channel 50 running through the interior of the device 30, which
starts at the hole in the cap 47 at the proximal end 41 and
continues through the body 35, ending at a small hole 49 in the
distal end of the retractor 37 where the two halves of the body
35a, 35b come together. When the cap 40 is unscrewed from the body
35, the two halves of the body 35a, 35b may be moved apart from one
another, as illustrated in FIG. 3.
[0072] Alternate Embodiment of the Retractor
[0073] Another preferred embodiment of the invention is illustrated
in FIGS. 9-10. In this embodiment, the retractor 100 includes a
retraction mechanism whereby the two halves 102a, 102b of the
retractor body 102 can be moved apart from one another a desired
distance, while maintaining their alignment. The retractor again
comprises a body portion 102, and an annular cap 104. The two
halves 102a, 102b of the body are initially held together by the
internally threaded 105 cap 104. This cap 104 is screwed on and off
the externally threaded halves 102a, 102b of the retractor body.
The outer surface of the cap 106 can be textured to ease hand
tightening and loosening of the cap 106. As illustrated in FIG. 10,
each half 102a, 102b of the retractor body again has a semicircular
groove 126 running longitudinally down the center of its flat
internal surface 128. When the cap 104 is securely screwed onto the
two halves 102a, 102b of the retractor body, such that the internal
surfaces 128 abut one another, the semicircular grooves 126 form a
channel 108. The cap 104 is open on both ends and through its
center to permit access to the channel 108.
[0074] The retractor 100, as illustrated in FIGS. 9-10, further
comprises a collar 110 located on the retractor body 102 just
distal to the externally threaded proximal end 103; a pin assembly
116, comprising two parallel pins 116a, 116b attached at one end to
a perpendicular handle 116c; and two set screws 120a, 120b. As
illustrated in FIG. 10, the pins 116a, 116b traverse guide passages
118a, 118b bored through the collar region 110b of one half 102b of
the retractor body and are insertable within holes 124a, 124b in
the collar region 110a of the other half 102a of the retractor
body, such that one half 102b of the retractor body can slide apart
from the other half 102a on the pins 116a, 116b. The collar 110b
includes internally threaded holes 122a, 122b adapted to receive
externally threaded set screws 120a, 120b. The set screw holes
122a, 122b enter the collar region 110a at right angles to the pin
guide passages 118a, 118b, such that when the set screws 120a, 120b
are advanced, they tighten upon the pins 116a, 116b and thus, fix
the distance between the two halves 102a, 102b of the retractor
body.
[0075] Second Alternate Embodiment of the Retractor
[0076] Yet another embodiment of the retractor of the present
invention is illustrated in FIGS. 21 and 22. The retractor 200
comprises a body portion 202 having a distal end 204, and a
broader, collar portion 206 at its proximal end 205. Like the
embodiment described above, this retractor 200 is formed in two
halves 202a, 202b and preferably has a tapered distal end 204. Each
half of the body of the retractor 202a, 202b, has a semicircular
groove 208 on its flat internal surface 209. When the two halves
202a, 202b are joined together, the semi-circular grooves 208 form
a channel 210 running through the interior of the device 200,
extending from the proximal end 205 to the distal end 204.
[0077] The collar 206 of the device 200 includes a pin assembly 212
comprising two parallel pins 212a, 212b attached at one end to a
handle 212c, and two set screws 214a, 214b. As illustrated in FIG.
22, the pins 212a, 212b traverse guide passages 216a, 216b bored
through the collar region 206 of one half of the retractor body
202b, and are insertable within holes 218a, 218b in the collar
region 206 of the other half of the retractor body 202a, such that
one half of the retractor body 202b can slide apart from the other
half 202a on the pins 212a, 212b. The collar 206 also includes
internally threaded holes 220a, 220b adapted to receive externally
threaded set screws 214a, 214b. The set screw holes 220a, 220b
enter the collar region 206 at right angles to the pin guide
passages 216a, 216b such that when the set screws 214a, 214b are
advanced, they tighten upon the pins 212a, 212b and thus, fix the
distance between the two halves of the retractor body 202a,
202b.
[0078] Third Alternate Embodiment of the Retractor
[0079] Still another embodiment of the retractor of the present
invention is illustrated in FIGS. 28 and 29. The retractor 300
comprises a distal body portion 302, and a proximal handle portion
304. The distal body portion 302 of the retractor 300 is formed in
two portions or halves 302a, 302b. At the distal end 306 of the
body portion 302, a retracting portion 308 extends away from, and
at an angle to the body portion 302. Preferably, the retracting
portion 308 extends substantially perpendicular to the body portion
302. The retracting portion 308 is also formed in two separable
portions or halves 308a, 308b. Each of these portions 308a, 308b
can be semi-circular in shape, or have a semicircular groove 312 in
its flat, internal surface (FIG. 29). The external surfaces are
preferably rounded, and tapered toward the distal end 310. When the
two portions 308a, 308b are brought together such that the two
portions abut one another, as seen in FIG. 28, a channel 314 is
formed through the interior of the retracting portion 308 of the
retractor 300.
[0080] Handles 316a, 316b are located at the proximal end 304 of
the retractor 300. The handles 316a, 316b are preferably elongate
and of a dimension sufficient to permit manipulation by hand. The
handles 316a, 316b are securely connected to the body portion 302
of the retractor 300. The handles 316a, 316b are used to control
the movement of the retracting portion 308 of the retractor
300.
[0081] FIGS. 28 and 29 also illustrate a loop 320 extending from
one of the handles 316a in the direction of the other handle 316b.
The other handle 316b has a screw 322 inserted therethrough. The
loop 320 surrounds the screw 322, such that when the screw 322 is
tightened, the loop 320 is held securely between the screw 322 and
the underlying surface. This mechanism acts to control the distance
between the handles 316a, 316b thereby controlling the distance
between the two halves of the retracting portion 308a, 308b. The
handles 316a, 316b, and the corresponding retracting portions 308a,
308b may be locked into any position by sliding the loop 320 along
the screw 322, then tightening the screw 322 to securely fix the
loop 320 in the desired position. Of course, other locking
mechanisms well known to those of skill in the art may also be used
to control the positioning of the retractor 300.
[0082] Fourth Alternate Embodiment of the Retractor
[0083] Yet another embodiment of the retractor of the present
invention is illustrated in FIGS. 48-50. The retractor 600
comprises a distal body portion 602 and a proximal handle portion
604. The distal body portion 602 of the retractor 600 is formed in
two portions or halves 602a, 602b. At the distal end 606 of the
body portion 602, a retracting portion 608 extends away from, and
at an angle to, the body portion 602. Preferably, the retracting
portion 608 extends substantially perpendicular to the body portion
602. The retracting portion 608 is also formed in two separable
portions or halves 608a, 608b. Each of these portions 608a, 608b
preferably has a semi-circular groove 612 in its internal surface.
The external surfaces are preferably rounded, and tapered toward
the distal end 610. When the two portions 608a, 608b are brought
together such that the two portions abut one another, as seen in
FIG. 49, a channel 614 is formed through the interior of the
retracting portion 608 of the retractor 600.
[0084] Handles 616a, 616b are located at the proximal end 604 of
the retractor 600. The handles 616a, 616b are preferably elongate
and of a dimension sufficient to permit manipulation by hand. Each
handle 616a, 616b is preferably formed as a unitary piece with a
corresponding body portion 602a, 602b, respectively. The handles
616a, 616b are used to control the movement of the retracting
portion 608 of the retractor 600. A hinge 618 operating between the
handle/body pairs 616a/602a, 616b/602b is adapted so that when the
handles 616a, 616b are moved away from each other, the body halves
602a, 602b are moved toward each other.
[0085] FIGS. 48-50 also show a stop bar 620 extending from one of
the handles 616b and through a cavity formed in the other handle
616a. The stop bar 620 is preferably curved along an arc having the
hinge 618 as a center of curvature. Teeth 622 are formed along a
surface of the arcuate stop bar 620. A ratcheting release member
624 comprising an arm 626 and a head portion 628 extends through
and from the handle half 616a through which the stop member 620
passes. The release member 624 is pivotably connected to the handle
half 616a by a pivot pin 630 extending through the head 628. The
head 628 comprises a stop 634, which is adapted to engage the teeth
622 of the stop bar 620, and a lobe 636 which extends through the
handle 616a. A bar spring 638 connected to the handle half 616a
contacts the lobe 636 and exerts a force F thereon. The force F
exerted by the bar spring 638 on the lobe 636 biases the head stop
634 into engagement with the stop bar teeth 622. The arm 626 of the
release member 624 is preferably arcuate and is adapted to be
easily manipulated by a hand also grasping the handles 616a, 616b.
Pulling the arm 626 toward the handle 616a overcomes the biasing
force F and moves the head stop 634 out of engagement with the stop
bar teeth 622.
[0086] A spring 640 is attached to and operates between the handles
616a, 616b. Preferably, the spring 640 is adapted to exert force F'
on the handles 616a, 616b, biasing the handles apart from each
other. Thus, the spring 640 biases the retracting portion halves
602a, 602b towards each other. Engagement of the release member
stop 634 in the stop bar teeth 622 is adapted to prevent movement
of the handles apart from each other. However, the release member
stop 634 is also adapted so that when the handles 616a, 616b are
squeezed toward each other, opening the retraction portion halves
602a, 602b, the head stop 634 "ratchets" over the teeth 622. Thus,
movement of the handle halves 616a, 616b toward each other is
accomodated by the stop 634, but movement of the handle halves
616a, 616b away from each other is prevented by the stop 634 when
it is engaged with the stop bar teeth 622. Thus, a clinician using
the retractor 600 can open the retractor halves 602a, 602b to a
precise point by simply squeezing the handle halves 616a, 616b
together. The stop 634 and stop bar 620 prevent the retractor
halves 602a, 602b from closing again once the desired open position
is reached. When the clinician desires to close the retractor 600,
the clinician need only manipulate the release member arm 626, thus
disengaging the stop 634 from the stop bar teeth 622. The hinge 640
then urges the handle halves 616a, 616b away from each other and
the retractor halves 602, 602b toward each other into the closed
position.
[0087] The retractors of the present invention are preferably
formed of one of many strong, biocompatible engineering polymers.
Plastics such as polypropylene, polyethylene, or polyterephthalate,
are preferred. Elastomers such as silastics or silicones can also
be used. Most preferably, metals such stainless or surgical steel,
or titanium, are used to form the retractor.
[0088] Construction of the Dilator
[0089] As illustrated in FIGS. 11-13, the retractor 100 is
preferably used in conjunction with a dilator 150. As is known to
those of ordinary skill in the art, the hollow dilator 150
preferably includes a standard male connector 149, such as a Luer
connector, at its proximal end and is narrowly tapered at its
distal end 151. The inside diameter of the dilator channel 160 is
large enough to accommodate a guidewire 144, so that the dilator
150 can be fed along the guidewire 144 and into the lumen of the
femoral artery. Dilators are commonly used in procedures such as
angioplasty and angiography to enlarge the puncture site and
provide improved access to the femoral artery.
[0090] In one embodiment of the present invention, the dilator is
preferably notched 152 near its distal end 151 around its entire
circumference. This notch 152 provides a seat for the tapered
distal tips of the two halves 102a, 102b of the retractor body,
such that when the retractor 100 is closed upon the dilator 150,
the sharp distal tip of the retractor body 112 is buried in the
notch 152 of the dilator. This forms a smooth transition between
the dilator 150 and retractor 100 (FIG. 12). As will be explained
more fully below, when the guidewire 144 is inserted through the
dilator 150 and the dilator 150 is then inserted through the
retractor 100, (FIGS. 12-13), the dilator 150 lies securely within
the interior circular channel 108 (FIG. 9) running the length of
the retractor body 102.
[0091] The dilator 150 also preferably includes at least one
indicator hole 154. The dilator 150 illustrated in FIGS. 11-13
includes two indicator holes 154 directly opposed to one another,
located a few millimeters distal to the notch 152; the distance X
between the holes 154 and the notch 152 is preferably only slightly
larger than the thickness of the wall of the femoral artery.
[0092] Alternatively, a transducer-tipped pressure monitoring
catheter, mounted to the outside of the dilator 150, may be used in
conjunction with the dilator 150 and indicator holes 154. Use of
the indicator holes 154 and pressure sensor will be described in
detail below.
[0093] Dilator/Retractor Assembly
[0094] Another embodiment of the present invention comprises an
entire femoral artery localization and closure assembly illustrated
in FIG. 13. The guidewire 144 which emerges from the original
puncture wound is fed through the dilator 150, and then the dilator
150 is inserted through the retractor 100. The retractor 100 is
advanced along the dilator 150 until the distal tips of the
retractor 112 stop within the notch 152 in the dilator 150.
Preferably, the male fitting 149 on the proximal end of the dilator
150 is connected to one port of a commercially available 3-way
Y-connector 156. A syringe 158 or other means of applying negative
pressure is connected to one of the other ports on the Y-connector
156 and the proximal end of the guidewire 144 exits the Y-connector
156 via the remaining port. The Y-connector 156 therefore acts as a
seal at the proximal ends of dilator 150 and guidewire 144.
[0095] Alternate Embodiments of the Dilator
[0096] In another embodiment of the invention, a modified dilator
150 is used. As illustrated in FIG. 17, a double-sleeved balloon
170 is removably attached to the dilator 150 near its distal end
151, proximal to a single indicator hole 154. Preferably, the
balloon 170 is placed a distance from the indicator hole 154 which
is approximately the width of the arterial wall, e.g., about 1.5
mm. The inflatable, double-sleeved balloon 170 is angled at its
distal end 172 to allow the balloon to better fit the femoral
artery 10. The balloon 170 includes inflation means which allow the
balloon to be inflated and deflated from the proximal end of the
dilator 150. Use of the double-sleeved balloon 170 will be
described in detail below.
[0097] In yet another embodiment, illustrated in FIGS. 23-25, the
dilator 220 has both a double-sleeved balloon 222 and a second
inflatable balloon 224 mounted on its distal end 226. The
double-sleeved balloon 222 is removably attached to the dilator 220
near its distal end 226, proximal to the single indicator hole 228.
The second inflatable balloon 224 is mounted on the dilator 220
just distal to the indicator hole 228. When inflated, this second
balloon 224 helps anchor the dilator 220 in place in the femoral
artery 10, preventing the dilator 220 from being pulled out of the
artery 10 during the procedure. Thus, the distal, second balloon
224 is positioned together with the indicator hole 228, within the
artery 10, while the double-sleeved balloon 222, proximal to the
indicator hole 228, remains outside of the artery 10 as illustrated
in FIG. 25. The balloons 222, 224 assist in the proper positioning
of the dilator 220, and help anchor the dilator 220 once it is
properly positioned, as will be explained in detail below.
[0098] The inner sleeve 230 of the double-sleeved balloon 222 is
preferably shaped to facilitate the insertion of the retractor 200
between the two sleeves 229, 230, as will be described in more
detail below. As illustrated in FIG. 24, the inner sleeve 230 can
be in the shape of an "I", thus providing additional space between
the inner surface of the outer sleeve 229, and the outer surface of
the inner sleeve 230. This allows the two halves of the retractor
body 202a, 202b to be inserted between the two sleeves 229, 230
more easily. The two sleeves of the balloon 229,230 can be shaped
in any form that would help facilitate insertion of the retractor
200.
[0099] The dilator 220 having both a double-sleeved balloon 222 and
a second, distal balloon 224, is further illustrated in FIG. 26. As
can be seen from the drawing, the dilator 220 has 4 different
lumens 232, 234, 236, 238 extending from the proximal end of the
dilator 225 to the distal end of the dilator 226. A guidewire 240
is inserted through one of the lumens 236. Another lumen 232 is
used to inflate the double-sleeved balloon 222, while a third lumen
238 is used to inflate the second balloon 224 at the distal end of
the dilator 226. The fourth lumen 234 is used to aspirate blood
through the indicator hole 228 at the distal end of the dilator
226. Syringes are preferably used to provide the aspiration and
inflation pressure through these lumens 232, 234, 236, 238. The
proximal end of the dilator 225 is preferably adapted to allow for
fluid communication between the syringes and the various lumens
232, 234, 236, 238 in the dilator. Of course, other means of
aspirating blood and inflating the balloons may also be used, and
connectors specifically adapted for these devices can be attached
at the proximal end of the dilator 225 to accommodate the means
chosen.
[0100] Dual Lumen Catheter
[0101] In yet another embodiment of the invention, a dual-lumen
catheter is used to locate the exact site of the puncture wound. As
illustrated in FIGS. 30 and 31, the catheter 340 has an inner lumen
342 which extends from the proximal end of the catheter 344 all the
way to the distal end of the catheter 346. This inner lumen 342 is
adapted to receive an inner catheter 360 or guidewire 350, as will
be explained in more detail below.
[0102] The outer lumen of the dual-lumen catheter 340 surrounds the
inner lumen 342, and also extends from the proximal end of the
catheter 344 to the distal end 346. Near the distal end of the
catheter 346, at least one indicator hole 352 is positioned in the
outer wall of the catheter 340. The indicator hole 352 provides
fluid communication between the area outside of the catheter 340
and the outer lumen. The outer surface of the catheter 354
surrounding the indicator hole 352 is preferably raised, acting as
a stop. Preferably, the distance between the indicator hole 352 and
the proximal end of the raised surface of the retractor 354, is
approximately the same as the thickness of the wall of the femoral
artery. As will be explained below, the retractor 300 is first
mounted on the distal end of the catheter, and positioned such that
the distal tip of the retracting portion 310 stops just proximal to
the raised surface 354, about 0.5 mm proximal to the indicator hole
352. This assures that the distal tip of the retracting portion 310
will be properly positioned inside the patient's body at the site
of the wound in the artery.
[0103] At the proximal end of the catheter 344, the proximal end
358 of the outer lumen is preferably joined to a connector 364,
such as a Luer-type connector, which is adapted to receive a
syringe 360 or other source of negative pressure, as will be
explained in more detail below.
[0104] The Surgical Clip Applicator
[0105] The retractor of the present invention is used to facilitate
closure of wounds to the vasculature of a patient using surgical
clips, staples, or sutures. One aspect of the present invention
therefore includes the use of a surgical clip applicator 70. A
surgical clip applicator 70 for use with the retractor 30 of the
present invention is illustrated in FIG. 5. As shown in this
figure, the distal end of the clip applicator 75 is fitted with two
triangular protrusions or wings 77a, 77b that extend laterally from
the sides of the distal end of the clip applicator 75. These wings
77a, 77b are configured to fit within the grooves 65 located on the
interior surface of the two halves 35a, 35b of the body of the
retractor 30, as is best seen in FIG. 8. With the wings 77a, 77b of
the clip applicator 70 in the grooves 65 in the two halves of the
body of the retractor 35a, 35b, the clip applicator 70 is guided
into proper position within the patient's body, as will be
discussed in more detail below. In addition, the surgical clip
applicator 70 preferably has a guide 80 attached to its distal end
75. The guide 80 preferably extends laterally from the side of the
clip applicator 70, and is open at its proximal and distal ends
such that a guidewire 20 may be threaded therethrough. This guide
80 is used in combination with the guidewire 20 to accurately guide
the clip applicator 70 to the site of the vascular puncture 25, as
will be described below.
[0106] The surgical clip applicator 70 preferably also has a stop
85 located proximal of the distal end 75, at the point where the
proximal ends of the wings of the applicator 77a, 77b end. As will
be explained, the stop 85 also aids in the proper positioning of
the clip applicator 70 at the site of the vascular puncture 25, and
prevents the clip applicator 70 from being inserted too far into
the patient's body.
[0107] Alternate Surgical Clip Applicator Assembly
[0108] Referring now to FIGS. 14-16, there is illustrated an
alternate embodiment of a surgical clip applicator assembly 130.
The clip applicator assembly 130 incorporates a standard
commercially available surgical clip applicator 132. In accordance
with the present invention, the applicator is modified to include a
guide assembly 134 reversibly fastened near its distal end. The
guide assembly comprises a winged guide plate 138 which is
reversibly secured to a body 140. In the embodiment illustrated in
FIGS. 14-16, allen screws 142 are used to attach the guide plate
138 but other well known means of attachment can also be used. The
distal end of the surgical clip applicator 132 slides within the
channel 148 (FIG. 15) formed when the winged guide plate 138 is
fastened to the guide body 140.
[0109] Attached to the guide body 140 is a guidetube 136 which is
adapted to accept the guidewire 144. A preferred embodiment of said
guidetube 136 includes a mechanism to close the guidetube 136 once
the guidewire 144 has entered. Such a mechanism may involve a
second partially open tube which fits within said guidetube 136.
This second tube can be rotated within the guidetube 136 to open
the guidetube 136 when the openings in both tubes are aligned or
close the guidetube 136 when the openings of the tubes are offset.
To facilitate the opening and closing, the inner tube preferably
includes a handle that passes through a slot in the outer guidetube
136. This mechanism can be spring-loaded like the closures commonly
used on pieces of jewelry.
[0110] The surgical clip applicator guide assembly 134, together
with the retractor 100 and the guidewire 144, is designed to
accurately guide the clip applicator 132 to the site of the femoral
artery puncture as detailed below. As explained above, the lateral
edges of the winged guide plate 138 are configured to fit within
the groove 126 (FIG. 10) located on the interior surface of each
half of the retractor body 102a, 102b. The surgical clip applicator
132 is guided between the retracted halves of the retractor body
102a, 102b following the guidewire 144 which passes through the
guidetube 136 at the distal most end of the surgical clip
applicator 132.
[0111] Second Alternate Surgical Clip Applicator Assembly
[0112] An alternate embodiment of the surgical clip applicator
assembly 250 is illustrated in FIG. 27. Again, the clip applicator
assembly 250 incorporates a standard commercially available
surgical clip applicator 252. The applicator 252 is modified to
include a guide assembly 254 reversibly fastened near its distal
end 256. The guide assembly 254 is adapted to receive an indicator
tube 260. The indicator tube 260 is a hollow tube having an
indicator hole 264 near its distal end 262. The indicator tube 260
is adapted to receive a guidewire 240 therethrough, and to be
connected to a source of negative pressure at its proximal end.
This source of negative pressure, such as a syringe, is used to
provide aspiration through the indicator hole 264. When properly
positioned on the clip applicator 252, the distal end of the
indicator tube 262 and the indicator hole 264 extend past the
distal end of the clip applicator 256. Preferably, the distance
between the indicator hole 264 and the distal tip of the clip
applicator 256 is approximately equal to the width of the arterial
wall, e.g., about 1.5 mm.
[0113] Methods of Use
[0114] Referring first to FIGS. 4-8, a first method of use of the
retractor 30 in conjunction with a surgical clip applicator 70 to
close a wound 25 in the femoral artery 10 will now be described. As
noted above, during angioplasty or angiography, the femoral artery
10 is first punctured with a hollow needle 15 and a guidewire 20 is
inserted therethrough (FIG. 4). A proximal portion of the guidewire
21 remains outside the patient's body. After the distal end of the
guidewire 23 is in position within the femoral artery 10, the
hollow needle 15 is removed. A catheter (not shown) is then
threaded over the guidewire 20, and inserted into the patient's
body.
[0115] In a preferred embodiment, a specially designed guidewire 20
having an inflatable balloon 24 located near its distal end 23 is
used for the diagnostic or therapeutic procedure. The guidewire 20
is threaded through the hollow needle 15 and into the patient's
vasculature. Alternatively, such as for balloon angioplasty
procedures, a standard guidewire well known to those of skill in
the art can be used in conjunction with a balloon catheter. The
balloon on the distal end of the catheter can be used in place of
the balloon 24 located on the guidewire 20.
[0116] Following completion of the therapeutic or diagnostic
procedure, the catheter used during the procedure is removed. The
guidewire 20 remains in place in the patient's vasculature. (Note
that when a balloon catheter is used in place of a guidewire having
a balloon on its distal end, the catheter is left inside the
patient, and use of its balloon is identical to the use of the
balloon 24 on the guidewire 20 described below). When the physician
desires to close the wound 25 in the femoral artery 10, he or she
first withdraws the guidewire 20 and/or catheter through the
patient's vasculature using the portion of the guidewire 20 and/or
catheter that remains outside the patient's body 21, until the
distal end 23 of the guidewire 20 and/or catheter is within the
femoral artery 10 close to the femoral artery puncture site 25. The
balloon 24 on the distal end 23 of the guidewire 20 or catheter is
then inflated, and the guidewire 20 or catheter is withdrawn
further until the physician feels some resistance. This will
indicate that the balloon 24 is inside the femoral artery 10 and at
the site of the puncture wound 25. The physician then threads the
proximal end of the guidewire 21 into the hole 49 located at the
distal end 37 of the fully assembled retractor 30 (FIGS. 2, 3 and
6). The guidewire 20 is threaded through the channel 50 formed in
the body of the retractor 35, until the proximal end of the
guidewire 21 emerges through the hole 47 in the cap 40 at the
proximal end of the retractor 41 (FIG. 6). The retractor 30 is then
slowly advanced along the guidewire 20 and into the patient's body,
until resistance is felt. This resistance indicates that the distal
tip of the retractor 37 is contacting the inflated balloon 24 in
the femoral artery 10. The distal tip of the retractor 37 therefore
will be properly located at the site of the puncture in the femoral
artery 25, as is shown in FIG. 6.
[0117] In a preferred embodiment, the guidewire 20 used in
conjunction with the femoral artery closure retractor 30 has a
marking 27 on it which also helps to indicate when the retractor 30
has been properly positioned (FIG. 6). This marking 27 preferably
consists of a tiny bead or colored line on the guidewire 20. The
marking on the guidewire 27 is placed proximal of the proximal end
of the balloon 26. The length of the retractor 30 is measured, and
the marking 27 is made at least that same length in a proximal
direction on the guidewire 20, measured from the proximal end of
the balloon 26. Thus, when the retractor 30 is advanced over the
guidewire 20 and resistance is felt, the physician checks to see if
the marking on the guidewire 27 has emerged through the proximal
end of the retractor 41, as is illustrated in FIG. 6. If the
marking 27 is not yet visible, the physician must advance the
retractor 30 further to ensure that it contacts the femoral artery
puncture site 25.
[0118] Once the retractor 30 is properly positioned within the
patient's body, the surgical clip applicator 70 or other method of
closing the puncture wound 25 is used. The cap 40 on the retractor
30 is first removed from the body by unscrewing (FIG. 3). The
proximal end of the guidewire 21 emerging from the proximal end of
the retractor 41 is threaded through the guide 80 located on the
outer surface of the applicator 70, as illustrated in FIG. 7. The
wings on the surgical clip applicator 77a, 77b are inserted into
the hole 90 formed at the proximal end of the body of the retractor
39, by lining up the wings 77a, 77b on the applicator 30 with the
grooves 65 located on the inner surface 67 of the retractor body
halves 35a, 35b (FIGS. 7 and 8). The wings on the clip applicator
77a, 77b are sized to fit within the grooves 65 of the retractor
30, as is best illustrated in FIG. 8. The clip applicator 70 is
then advanced, which causes the two halves of the body of the
retractor 35a, 35b to separate, as shown in FIG. 7. As the two
halves 35a, 35b separate, the patient's tissue is displaced
laterally, allowing better access to the puncture site 25 in the
femoral artery 10 below the overlying tissues. The clip applicator
70 is advanced through the retractor 30 until the stop on the
applicator 85 contacts the proximal end of the retractor 39. At
this time, the balloon on the guidewire 24 or catheter is deflated,
and the catheter and/or guidewire 20 is removed from the patient.
The surgical clips located at the distal tip of the clip applicator
75 are applied to the puncture wound 25, preferably using the
method well known to those of ordinary skill in the art. Once the
femoral artery puncture wound 25 is closed, the clip applicator 70
and retractor 30 are removed from the patient.
[0119] First Alternate Method
[0120] Referring now to FIGS. 9-16, a method of using the alternate
embodiment of the retractor 100 in conjunction with the dilator 150
and surgical clip applicator assembly 130 to localize and close the
femoral artery puncture wound is now described. As described above,
following completion of the angioplasty or angiography, the
catheter used during the procedure is removed from the patient's
body, leaving only the guidewire threaded into the femoral artery.
If desired, before the retractor-dilator assembly 101 (FIG. 13) is
used, a standard dilator of a smaller diameter than that 150
incorporated into the retractor-dilator assembly 101 can be fed
onto the proximal end of the guidewire and advanced down the
guidewire and into the artery. This preliminary step dilates the
overlying tissue if necessary, making it easier to subsequently
pass the larger retractor-dilator assembly 101 through the
surrounding tissue.
[0121] If the tissue has been dilated as above, the smaller bore
standard dilator is first removed. The proximal end of the
guidewire 144 is first inserted into the distal channel 160 (FIG.
11) of the dilator 150. The dilator 150 has been previously
inserted through the internal channel of the retractor 100, and the
retractor 100 advanced over the dilator 150 until the distal tip
112 comes to rest in the notch 152 on the distal tip of the dilator
150. The Y-connector 156 is then attached to the proximal end of
the dilator 150 and a syringe 158 attached to one of the ports of
the connector 156. The retractor-dilator assembly 101 is then
advanced over the guidewire 144 into the patient's body.
[0122] While the retractor-dilator assembly 101 is advanced into
the patient's body, suction is continuously applied via the syringe
158 or other means of negative pressure (FIG. 13) to the dilator
150. At the moment the indicator holes 154 enter the lumen of the
femoral artery, blood is aspirated into the syringe 158, indicating
that the dilator 150 has been inserted through the puncture site
into the femoral artery. Thus, the distal tip of the retractor 112,
still buried within the notch 152 in the dilator 150, is located
just proximal or outside the artery wall at the site of the
puncture wound and the indicator holes 154 in the dilator 150 are
located just distal or inside the artery lumen.
[0123] Alternatively, the dilator 150 includes a pressure sensor
(not shown) such as a fiber optic pressure sensor, near its distal
tip. The sensor is preferably mounted to the outside wall of the
dilator 150. In a preferred embodiment, a transducer-tipped
pressure monitoring catheter, such as the Camino Catheter available
from Camino Laboratories, San Diego, Calif., is used. The pressure
sensor, mounted on the outside of the dilator 150, is inserted over
the guidewire 144 and into the femoral artery. The pressure sensor,
in conjunction with a pressure monitoring system, will indicate an
increase in pressure when it is inserted into the femoral artery.
At that point, the advancement of the retractor 100 is stopped,
such that the distal tip of the retractor 112 is located just
proximal the artery wall 10 at the site of the puncture wound. This
allows the physician to properly locate the site of the femoral
artery puncture wound in the patient.
[0124] Once the dilator 150 and retractor 100 are in proper
position, the cap 104 is removed from the retractor 100 and the two
halves 102a, 102b of the retractor body are separated slightly
(FIG. 10) by loosening the set screws 120a, 120b and sliding the
two halves 102a, 102b of the retractor laterally away from one
another. This causes the distal tips 112 of two halves 102a, 102b
to emerge from the notch 152 in the dilator 150 (FIG. 11) and
straddle the puncture site. The set screws 120a, 120b, are then
tightened to hold the two halves 102a, 102b of the retractor 100 in
this separated position. While pressing the retractor 100 down
against the outer wall of the femoral artery, the dilator 150 is
withdrawn, leaving only the retractor 100 and the guidewire 144 in
position at the site of the puncture wound in the artery.
[0125] To close the wound, the retractor 100 must be retracted far
enough to allow the surgical clip applicator assembly 130 to access
the puncture site. Upon loosening the set screws 120a, 120b, the
two halves 102a, 102b of the retractor are further separated by
applying pressure on the retractor pin handle 116c (FIGS. 9-10).
When sufficiently retracted, the set screws 120a, 120b on the
retractor assembly 100 are tightened to maintain the proper
distance between the retractor halves. If necessary, a separate
retractor, having a thickness suited for sliding within the grooves
126 in each half 102a, 102b of the retractor body, and a width
equal to that of the winged guide plate 138 (FIG. 14) of the
surgical clip applicator guide assemble 134, can be used to open
the retractor body to the proper distance.
[0126] Second Alternate Method
[0127] In an alternate embodiment illustrated in FIG. 17, the
modified dilator 150 having a double-sleeved inflatable balloon 170
removably attached to the distal end of the dilator 151, just
proximal to the indicator hole 154, is used. The balloon dilator
apparatus 175 is inserted over the guidewire 144 into the patient's
body. As described above, as the balloon-dilator apparatus 175 is
advanced, negative pressure is applied to the system via the
syringe or other source. The advance of the balloon-dilator
apparatus 175 is stopped as soon as blood is aspirated. The
double-sleeved balloon 170 is then inflated to form a tunnel 176
between the femoral artery puncture wound and the surface of the
patient's body, as illustrated in FIG. 18.
[0128] The double-sleeved balloon 170 advantageously prevents the
femoral artery closure retractor 100 from entering the femoral
artery 10 and damaging it. Should the deflated balloon 170 be
advanced into the femoral artery 10, the process of inflating the
balloon 170 will pull the balloon 170 out of the artery 10, thereby
safely creating a tunnel 176 used to access the artery 10.
[0129] The balloon 170 is preferably angled at its distal end 172
to allow the balloon 170 to "fit" the femoral artery 10, as shown
in FIGS. 17-19.
[0130] Once the balloon 170 is inflated (FIG. 18) the retractor 100
is advanced between the two sleeves of the balloon 170, until the
distal tip of the retractor 112 reaches the distal end of the
double sleeved balloon 170. Once the retractor 100 is positioned
between the two sleeves of the balloon 170, the two halves of the
retractor 102a, 102b are moved laterally away from one another, as
described above. The inner sleeve 178 and the dilator 150 are
removed from the patient, leaving the separated retractor 100 and
the outer sleeve 180 of the balloon 170 in the patient. The dilator
150 and the inner sleeve 178 are removed from the patient along the
guidewire 144.
[0131] The retractor 100 and the outer sleeve of the balloon 180
form an access tunnel 182 between the femoral artery puncture wound
and the surface of the patient's body, as illustrated in FIG. 20.
This tunnel 182 allows for the introduction of the wound closure
device to seal the femoral artery puncture wound.
[0132] At this point, with the retractor providing access to the
femoral artery, the proximal end of the guidewire 144 is inserted
into the guidetube 136 on the surgical clip applicator assembly 130
and the wings on the guide plate are fitted within the grooves 126
of the opened retractor body 102 (FIGS. 14-16). The clip applicator
assembly 130 can now be advanced toward the puncture wound, sliding
within the grooves 126 in the retractor body 102, guided by the
guidewire 144 passing through the guidetube 136 at the distal tip
of the surgical clip applicator assembly 130. When the distal tip
of the surgical clip applicator 130 has reached the outer wall of
the femoral artery 10, at the site of the puncture wound, the
surgeon withdraws the guidewire 144 from the patient's body and
immediately deploys a surgical clip. A second clip can then be
deployed a millimeter or two away from the first clip in order to
ensure that the wound is closed.
[0133] In a preferred embodiment, just prior to closure of the
puncture site, the flexible guidewire 144 used during the primary
procedure is replaced with a commercially available guidewire that
can become rigid at its distal end, forming a hook. The hooked
distal end can be pulled back, "hooking" the puncture wound in the
artery. As the guidewire is pulled back further, the puncture wound
is stretched into a linear slit, making it more amenable to closure
by surgical clips.
[0134] Third Alternate Method
[0135] Referring now to FIGS. 21-27, a method of using the
alternate embodiment of the retractor 200 in conjunction with the
dilator 220 and surgical clip applicator assembly 250 to localize
and close the femoral artery puncture wound is now described. As
described above, following completion of the angioplasty or
angiography, the catheter used during the procedure is removed from
the patient's body, leaving only the guidewire 240 threaded into
the femoral artery 10.
[0136] The proximal end of the guidewire 240 is first inserted into
the distal lumen 236 (FIG. 26) of the dilator 220. The dilator 220
is advanced over the guidewire 240 into the patient's body. As
described above, as the balloon-dilator apparatus 250 is advanced,
negative pressure is applied to the system via the syringe or other
source connected at the proximal end of the dilator 225. The
advance of the dilator 220 is stopped as soon as blood is aspirated
through the indicator hole 228, thus indicating that the distal end
of the dilator 226 is positioned within the femoral artery 10. The
distal balloon 224 and the double-sleeved balloon 222 are then
inflated to anchor the dilator 220 in place and to form a tunnel
between the femoral artery puncture wound and the surface of the
patient's body.
[0137] Once the balloons 222, 224 are inflated, the retractor 200
is advanced between the two sleeves 229, 230 of the double sleeved
balloon 222. As illustrated in FIG. 24, the inner sleeve 230 of the
double sleeved balloon 222 can be in an "I" shape, which provides
more space between the two sleeves to insert the two halves 202a,
202b of the reactor 200. The retractor 200 is advanced between the
two sleeves 229, 230, as described above, until the distal tip of
the retractor 204 is positioned just proximal to the puncture wound
in the femoral artery 10.
[0138] Once the retractor 200 is positioned between the two sleeves
of the balloon 229, 230, the two halves of the retractor 202a, 202b
are moved laterally away from one another. This is done by
loosening the set screws 214a, 214b, and sliding one half of the
retractor body 202b away from the other half 202a on the pins 212a
212b. The inner sleeve 230 of the double-sleeved balloon 222 and
the dilator 220 are removed from the patient along the guidewire
240, leaving the separated retractor 200 and the outer sleeve 229
of the balloon 222 in the patient. The retractor 200 and the outer
sleeve of the balloon 229 form an access tunnel between the femoral
artery puncture wound and the surface of the patient's body. This
tunnel allows for the introduction of the wound closure device to
seal the femoral artery puncture wound.
[0139] At this point, with the retractor 200 and outer sleeve of
the balloon 229 providing access to the femoral artery 10, the
proximal end of the guidewire 240 is inserted into the distal end
262 of the indicator tube 260 which is mounted on the surgical clip
applicator 252. As described above, the distal end 262 of the
indicator tube 260 having an indicator hole 264 in it is positioned
so that the indicator hole 264 extends past the distal end 256 of
the clip applicator 252. The indicator tube 260 and the clip
applicator 252 are advanced over the guidewire 240 while aspiration
pressure is applied to the proximal end of the indicator tube 260.
As soon as blood is aspirated through the indicator hole 264, the
advancement of the indicator tube 260 and clip applicator 256 is
stopped. At this point, the distal end of the surgical clip
applicator 256 is positioned at the site of the puncture wound in
the femoral artery 10. Surgical clips are then applied to seal the
wound.
[0140] Preferably, the distal end of the indicator tube 262 is
curved or hooked. The hooked distal end is used to hook the
puncture wound in the artery, bringing the edges of the wound
together to facilitate application of the clip. Using the hooked
distal end 262 of the indicator tube 260, the puncture wound is
stretched into a linear slit, making it more amenable to closure by
surgical clips.
[0141] Fourth Alternate Method
[0142] Referring now to FIGS. 28-31, still another method of
closing a wound in the femoral artery of a patient will be
described. Here again, the femoral artery is first punctured with a
hollow needle and a guidewire 350 is inserted therethrough. A
proximal portion of the guidewire 351 remains outside the patient's
body. After the distal end of the guidewire 353 is in position
within the femoral artery, the hollow needle is removed. Diagnostic
and/or therapeutic procedures are then carried out, using the
guidewire 350 to guide the insertion of the other medical
instruments into the vasculature of the patient.
[0143] Following completion of the therapeutic or diagnostic
procedure, the devices used during the procedure are removed. The
guidewire 350 remains in place in the patient's vasculature. When
the physician desires to close the wound in the artery, he or she
first mounts the retractor 300 on the distal end of the dual-lumen
catheter 340. This is done by loosening the screw 322 on one of the
handles 316b, and moving the handles 316a, 316b away from one
another to separate the two halves of the retracting portion 308,
and the two parts of the retracting portion 308a, 308b are
positioned around the dual-lumen catheter 340. The dual lumen
catheter 340 fits within the semi-circular channel or grooves 312
formed in the inner surface of the retracting portion 308 of the
retractor 300. The two halves of the retracting portion 308a, 308b
are brought together using the handles 316a, 316b to surround the
catheter 340. The retracting portion 308 is positioned on the
catheter 340 just proximal to the raised portion of the catheter
354, so the distal tip of the retracting portion 310 is located
just proximal to the indicator hole 352. Preferably, the distal tip
of the retracting portion 308 will be approximately 0.5 mm behind
the indicator hole 352 (see FIG. 31). Once in position, the screw
322 is tightened on the loop 320 to lock the two parts of the
retracting portion 308a, 308b in position on the catheter 340.
[0144] Once the retractor 300 is properly positioned on the
dual-lumen catheter 340, the physician inserts the proximal end 351
of the guidewire 350 into the distal end of the inner lumen 342 in
the dual-lumen catheter 340. The dual-lumen catheter 340 and
retractor 300 are advanced over the guidewire 350 and into the
patient. As the catheter 340 and retractor 300 are advanced,
negative pressure is applied to the outer lumen of the catheter,
for example, through use of a syringe 360 attached to the proximal
end of the outer lumen 358. Once the indicator hole 352 is advanced
to a position inside the artery, blood will be drawn through the
indicator hole 352 and will become visible in the outer lumen of
the catheter 340 and the syringe 360. At this point, advancement of
the catheter 340 and retractor 300 are stopped, as the catheter 340
and retractor 300 are properly positioned in the patient.
[0145] Once properly positioned at the site of the puncture wound,
the two halves of the retracting portion 308a, 308b are separated
slightly, using the handles 316a, 316b at the proximal end 304 of
the retractor 300. To separate the retracting portions 308a, 308b,
the screw 322 is loosened, and the handles 316a, 316b manipulated
into the desired position. The screw 322 is then tightened down
upon the loop 320, prohibiting further movement of the handles
316a, 316b, and the corresponding retracting portions 308a,
308b.
[0146] At this point, the surrounding tissues have been displaced,
forming an access path to the puncture wound, and the puncture
wound may be visible. The dual-lumen catheter 340 is removed from
the patient by withdrawing it over the guidewire 350. The guidewire
350 is left in place, and the wound closure device, such as a clip
applicator, is inserted over the guidewire 350 to the site of the
wound. Clips, such as those made of titanium or a biodegradable
material, are preferably applied to the wound, as the guidewire 350
is removed. If necessary, the artery is compressed to stop the flow
of blood out of the puncture wound during the closing of the wound.
The closing device is removed when the physician is confident that
the wound is closed, and the retractor 300 is removed from the
patient.
[0147] Alternatively, a separate inner catheter 360 is used in the
system of the present invention. In this embodiment, once the
retractor 300 and dual-lumen catheter 340 are in place, and the
retracting portion 308 is in an open position, the dual-lumen
catheter 340 is left in place, and the guidewire 350 is withdrawn
from the patient through the inner lumen 342. An inner catheter 360
having an inflatable balloon 362 at its distal end is inserted
through the inner lumen 342 and into the patient. Once the distal
balloon 362 is advanced past the distal tip 346 of the dual-lumen
catheter 340, the balloon 362 is inflated. The dual-lumen catheter
340 is removed from the patient, leaving the inner catheter 360 in
place.
[0148] To properly position the balloon inside the patient's
artery, the physician can measure the distance from the distal tip
of the dual-lumen catheter 346 to just outside the patient's body
when the catheter 340 is properly positioned. The physician then
inserts the inner catheter 360 just slightly more than that
distance, to ensure that the distal balloon 362 is within the
artery. The physician then pulls the inner catheter 360 in a
proximal direction until resistance is felt. This will place the
balloon 362 at the site of the puncture wound. The balloon 362 is
properly positioned just inside the artery of the patient. The
balloon 362 helps to stop the flow of blood out of the puncture
wound. The inner catheter 360 is used as a guide for the clip
applicator or other closing device used to close the wound. The
closing device is advanced until it contacts the inflated balloon
362. As the wound is closed, the balloon 362 is slowly deflated,
and the inner catheter 360 is removed from the patient. Finally,
once the physician is confident that the wound is closed, the
retractor 300 is removed from the patient.
[0149] This method of closing a wound in the femoral artery of a
patient can also be performed using the retractor 600 described in
FIGS. 48-50 in place of the retractor 300 discussed above. To mount
the retractor 600 on the distal end of the dual lumen catheter 340,
the clinician squeezes the release member arm 626 so that the head
stop 664 is clear of the stop member teeth 622. The handles are
also squeezed together in order to separate the two halves 608a,
608b of the retracting portion so that the retracting portion
halves may be positioned around the dual lumen catheter 340. As
above, the catheter fits within the semi-circular channel or
grooves 612 of the retracting portion halves 608a, 608b. When the
retracting portion 608 is positioned on the catheter 340 just
proximal to a raised portion of the catheter so that the distal tip
610 of the retracting portion 608 is located just proximal to the
indicator hole 352, the clinician releases the squeezing hold on
the handles 616a, 616b. Thus, the spring 640 urges the retracting
halves 608a, 608b to close around the catheter. The force F'
exerted by the spring 640 on the handles 616a, 616b operates to
retain the catheter 340 securely between the retractor halves 602a,
602b.
[0150] The dual lumen catheter 340 and retractor 600 are next
advanced over the guidewire, preferably in the same manner
described above, until the assembly is properly positioned at the
vascular puncture wound. The retracting portions 608a, 608b are
next separated in order to displace the surrounding tissue. To
separate retracting portions, the clinician squeezes the handles
616a, 616b. During the squeezing operation, the head stop 634
ratchets over the stop member teeth 622. Thus, when the desired
open position is reached, the clinician need only release the
handles 616a, 616b and the stop 634 will engage the teeth 622 in
order to hold the retracting halves 608a, 608b in the chosen open
position. With the surrounding tissues displaced, forming an access
path to the vascular puncture wound, the vascular wound can be
closed by using a suitable apparatus or method.
[0151] To remove the retractor 600 from the patient, the retracting
portions 608a, 608b are first brought together into the closed
position by the clinician squeezing the release arm 626 toward the
handle 616a. The stop 634 is thus disengaged from the stop arm
teeth 622 and the spring 640 urges the handles 616a, 616b apart.
Thus, the retracting portions 608a, 608b are drawn together into
the closed position. The retractor 600 is then easily removed from
the patient.
[0152] Alternate Apparatus for Vessel Closure
[0153] Referring now to FIG. 32, there is illustrated another
apparatus contemplated for closure of an opening in a vascular
organ, e.g., blood vessel subsequent to an angiography, angioplasty
procedure, etc. Apparatus 400 includes vascular closure instrument
402 and a vacuum source 404 (shown schematically in FIG. 32) which
is connectable to the vascular closure instrument. Vacuum source
404 may be any vacuum generator suitable for the surgical procedure
to be described.
[0154] With references to FIGS. 32-34, vascular closure instrument
402 includes handle 406, and an elongated portion 408 extending
distally from the handle 406 and defining longitudinal axis 408a.
Handle 406 is generally cylindrical in configuration, however,
other designs are contemplated as well. Vascular closure instrument
402 includes a longitudinal lumen 410 extending the length of the
instrument 402 through handle 406 and elongated portion 408 and
terminating in distal axial opening 412. Longitudinal or vacuum
lumen 410 conveys the vacuum provided by vacuum source 404. FIG. 34
illustrates suitable tubing "t" connecting vacuum source 404 and
closure instrument 402.
[0155] Vascular closure instrument 402 further includes a pair of
surgical clips 414 supported at the distal end of elongated portion
408. Surgical clips 414 may be any conventional surgical clip
fabricated from a suitable biocompatible material including
absorbable and non-absorbable materials. Clips 414 are
characterized by having backspan 414a and clip legs 414b (FIG. 35).
Clip legs 414b are adapted to move or pivot inwardly to a closed or
formed condition thereof in response to inward force applied to the
clip legs 414b.
[0156] Surgical clips 414 are releasably mounted to elongated
portion 408. In one arrangement, elongated portion 408 includes
first and second pairs of longitudinal grooves 416 formed in the
distal end of the elongated portion 408. Longitudinal grooves 416
extend in a longitudinal direction and terminate in transverse
grooves 418 (FIG. 33) adjacent the proximal end of the longitudinal
grooves 416. Transverse grooves 418 receive surgical clips 414,
more specifically, backspans 414a of the surgical clips 414 to
mount the surgical clips 414 in a releasable manner. Transverse
grooves 418 are preferably dimensioned such that a frictional
relationship is established to further facilitate mounting of the
clips 414 to the instrument 402. Each surgical clip 414 is loaded
by positioning backspan 414a within longitudinal groove 416,
advancing the clips 414 in a proximal direction adjacent transverse
grooves 418 and manipulating the backspans 414a to be received
within the transverse groves 418. Other means for mounting surgical
clips 414 to elongated portion 408 may be readily appreciated by
one skilled in the art.
[0157] With continued reference to FIGS. 32-35, vascular closure
instrument 402 further includes clip forming mechanism, generally
identified as reference numeral 420, mounted to elongated portion
408 of the instrument. In the preferred embodiment, clip forming
mechanism 420 includes a pair of manually operable levers 422
mounted to the outer surface of elongated portion 408 in
diametrically opposed relation. Manually operable levers 422 are
mounted at their proximal end portions via mounting pins 424
whereby the distal end portions of the manually operable levers 422
may move in a radially direction, i.e., toward each other, to form
surgical clips 414.
[0158] As best depicted in FIGS. 32-33, elongated portion 408
defines a non-circular or oval cross-section having a major
cross-sectional dimension "a" (FIG. 33). Such configuration
advantageously facilitates closure of an elongated incision formed
in the blood vessel. In particular, an incision made in the blood
vessel in connection with an angioplasty or angiography procedure
is preferably elongated in the direction of the axis of the blood
vessel. Accordingly, by applying vascular closure instrument 402 to
the opening with the major axis "a" extending in the general
direction of the opening, the surgeon is assured that the vessel
opening is confined within the perimeter of the elongated portion
408. In addition, the oval cross-section corresponds to the
internal dimension of the aforedescribed retractors, including
retractor 100 and retractor 300, when in an open condition, thereby
facilitating use of the wound closure instrument 402 with these
instruments, e.g., positioning of the closure instrument 402 within
the open retractor and advancing the instrument 402 therewithin.
For a typical puncture wound having a diameter or length of about 1
mm, the elongated portion 408 preferably has a major axis "a" of
about 3-5 mm and most prefrably about 4 mm.
[0159] Elongated portion 408 of vascular closure instrument may
further include a wrap 425, e.g., shrink wrapping, or the like
shown cut-away in FIG. 32. Wrap 425 preferably extends to the
distal end of elongated portion 408 of vascular closure instrument
402 to at least partially enclose longitudinal grooves 416 and
transverse grooves 418 to preserve the integrity of the vacuum
within vacuum lumen 408.
[0160] The operation of vascular closure instrument in conjunction
with closing an opening in a blood vessel wall will now be
discussed. Access to the puncture site is preferably achieved with
the guidewire, dilator, retractor instruments discussed above. With
reference to FIGS. 34-35, vascular closure instrument 402 is
positioned adjacent the opening "o" in vessel "v" with the major
axis of the oval extending in the general direction of the axis "a"
of the blood vessel "v." By virtue of the oval cross-section, the
entire opening or incision "o" is confined within the perimeter of
the elongated portion. Vacuum source 402 is actuated which thereby
creates a vacuum within vacuum lumen 410. Due to the effect of the
vacuum forces, shown in FIG. 34 by the directional arrows "s," the
vessel edge portions "e" defining the vessel opening "o" are at
least partially drawn into distal axial opening 412 of elongated
portion 408 to assume an everted condition as shown. With reference
now to FIGS. 36-37, with the vessel edge portions "e" everted and
in position to be engaged by clip legs 414b of surgical clips 414,
manually operable levers 422 are moved radially inwardly in the
direction of directional arrows "f" by a force exerted by the user
to pivot clip legs 414b and form surgical clips 414. In the formed
condition, clip legs 414b engage the vessel edge portions "e" to
generally approximate the edges "e" to close the opening.
Thereafter, surgical clips 414 are released from their mounting to
elongated portion 408 by manipulating the vascular closure
instrument 402 to align clip backspan 414a with longitudinal
grooves 416 thereby permitting the instrument to be withdrawn
leaving the surgical clips 414 in place.
[0161] FIGS. 38-39 illustrate an alternate embodiment of the
vascular closure instrument. In accordance with this embodiment, a
side opening port 430 (shown in phantom) is provided in the
elongated portion 408 to permit passage of the proximal end of a
guidewire "g." When used with the guidewire "g" in place within the
vessel opening, the guidewire "g" is introduced within distal
opening 412 and manipulated to the side opening port 430 and passed
therethrough. Thereafter, the vascular closure instrument is
advanced along the guidewire to the opening site. As best depicted
in FIG. 39, the guidewire "g" is preferably positioned adjacent the
periphery of the elongated portion 408 so as to not interfere with
the clip forming process. More preferably, the guidewire "g" is
placed about 1/4-1/2 of the length of the major axis "a" from the
periphery of the axial opening 412 so as not to interfere with the
everted vessel edges. Most preferably, the guidewire "g" is
positioned about 1/3 of the length of the major axis "a" into the
opening 412. Also, a separate guidewire lumen or tube may be
incorporated in elongated portion 408 to receive the guidewire "g."
If in the form of a tube, such tube may be attached to the inner
wall of elongated portion 408 and extend to side opening port
430.
[0162] Locating a Tissue Opening
[0163] Referring to FIGS. 40-41, an apparatus and method for
locating a vessel opening is described. In FIG. 40, the locator
apparatus 500, which is in communication with a vacuum or source of
suction (not shown), has not completely isolated the vessel opening
25. Thus, the locator apparatus 500 draws both blood and other
bodily fluid with its suction. In FIG. 41, the locator apparatus
500 has completely isolated the vessel opening 25 and now only
draws blood through its lumen. The blood is transferred to the
proximal end of the apparatus 500 or to some other location
external of the body to provide a visual indication that the
apparatus 500 has located the opening 25. In this position, the
locator apparatus 500 can hold onto the vessel 10 with its suction
and maintain the apparatus 500 over the opening.
[0164] Referring to FIGS. 42a and 42b, an alternate locator
apparatus 500 is shown with an external guidewire lumen 507. An
internal guidewire lumen 508 is shown in FIG. 42b.
[0165] Referring to FIG. 43, a preferred locator apparatus 500 is
shown with external medical delivery devices 508a and 508b, which
can deliver medical treatment to the area surrounding the vessel
opening 25. Also, internal medical delivery devices 509a and 509b
can deliver medical treatment to the vessel opening 25 or to the
vessel 10 itself. The medical treatment can be therapeutic, e.g.
radiation or drug delivery.
[0166] Referring to FIG. 47, a preferred apparatus for locating a
vessel opening is illustrated. Suction apparatus 500 includes a
vacuum source 505 (shown schematically). The suction apparatus 500
may also be connected to a closure device 504 (shown schematically)
via attachment ports 506. Vacuum source 505 may be any vacuum
generator suitable for the surgical procedure to be described. The
apparatus 500 may also include closure devices 504 (shown
schematically), which may also be inside the apparatus 500.
[0167] Referring to FIGS. 44-47, a method of locating a vessel
opening is illustrated. In particular, a guidewire "g" is strung
though the vessel opening as described previously. The suction
apparatus 500 has the guidewire "g" strung through it by the
guidewire guide 503. As the distal axial opening 502 nears the
vessel opening 25, the vacuum forces of the suction apparatus 500
draws both blood and clear bodily fluid from the area surrounding
the vessel opening 25. When the distal axial opening 502 completely
covers the vessel opening 25, the suction apparatus 500 has
isolated the vessel opening 25. At this point, the vacuum forces of
the suction apparatus 500 only draws blood. Also, once the vessel
opening 25 has been isolated, the vacuum forces of the suction
device 500 cause the edges of the vessel opening 25 to evert
26.
[0168] Once the vessel opening 25 has been isolated, a closure
device 504 attached to the suction device 500 can be used to close
the vessel opening 25.
[0169] The present invention can also be used with surgical staples
or sutures. After the retractor is inserted into the patient's body
and positioned at the puncture site as described above, the two
halves of the retractor are separated, laterally displacing the
tissues surrounding the puncture site. The retractor acts much like
a dilator, gradually increasing the displacement of the overlying
tissues, until the puncture wound is visible to the physician. The
wound can then be closed using any acceptable means for wound
closure, including surgical staples and sutures.
[0170] Although certain embodiments and examples have been used to
illustrate and describe the present invention, it is intended that
the scope of the invention not be limited to the specific
embodiments set forth herein. The scope of the invention is to be
defined by the claims which follow.
* * * * *